Improved Assessment, Diagnosis and Management of Brain Injuries

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By David Stern

Recent events have served as sad yet significant reminders of the seriousness of head injuries or traumatic brain injuries (TBIs).

As the football season ramped up, two tragic incidents took place in October alone. Christion Abercrombie, a linebacker for Tennessee State University, was rushed to the hospital and underwent life-saving emergency brain surgery after suffering a severe head injury. In Georgia, Pike County High School linebacker Dylan Thomas also sustained a severe head injury and was rushed to the hospital for surgery, but he tragically passed away soon afterwards.

The frequency and health risks of traumatic brain injuries, which include sports-related concussions, are increasingly being discussed and studied. As indicated in Table 1, there are close to 4 million sports-related concussions each year, with an additional 50% not being reported. The risks of not properly diagnosing and treating a brain injury are severe.

A concussion temporarily disrupts mental function and if not treated, it can have debilitating long-term consequences. People with an untreated concussion may suffer from headaches and fatigue—sometimes for years. They are not as sharp as they should be mentally, and they have problems focusing.

Additionally, not promptly diagnosing a concussion and allowing an athlete to return to play even further increases their chance of harm. Right after a concussion, people are at much higher risk for further injury since they are not able to react or think quickly. Also, the brain is very sensitive after an injury. Reinjuring the brain while concussed can lead to very serious health problems—far more serious than one injury. Researchers have found that individuals who have suffered multiple concussions during their lifetime increase their chances of depression, post-traumatic stress syndrome (PTSD) and suicide by 1.5x to 3x.

Another very harmful immediate possible outcome of a head injury is a brain hemorrhage or brain bleed, which is a type of stroke. This can be a life-threatening situation. The presence of blood in the brain increases pressure on nearby brain tissue, and that reduces vital blood flow and can damage brain cells. Typically, a trip to the hospital for a CT Scan, a special X-ray test, is necessary to detect brain bleeding. Having the ability to quickly identify a brain injury and provide treatment can save lives. Yet, this can be challenging, as many tests are subjective and are generally focused on how the player feels, their ability to answer simple questions, repeat numbers and words in proper sequence and maintain balance. These types of tests cannot reliably identify brain injuries and the severity if present. Fortunately, there is a new device that is changing the way medical professionals evaluate and treat concussions. 

Electrical signals course through the brain and when someone has a brain injury these electrical signals change and are different from those that would be present in an uninjured brain.  The brain’s electrical signals can be measured and tracked by an electroencephalogram (EEG). A unique, FDA-cleared medical device named BrainScope® One uses the EEG signal to determine whether the patient likely has a brain bleed. The BrainScope One device has been thoroughly tested and has demonstrated that it can identify patients with as little as 1cc of brain blood with 99% success rate. This assessment function is referred to as a Structural Injury Classifier.

Dr. Manu Mehdiratta, a neurologist who specializes in concussion and works at the Trillium Health Centre in Mississauga, Canada explains, “The Structural Injury Classifier helps determine the need for a CT scan or advanced neuroimaging. Basically, this will tell you with a high level of certainty whether or not there is likely a  bleed in the brain, which is very useful.”

Dr. Leigh Vinocur, Emergency Room Physician, and Chief Medical Director at MedStar PromptCare Clinics says, “I was excited about BrainScope when I first learned about it because it’s 99 percent sensitive for picking up a structural injury and a bleed, even down to 1 cc of blood, which is such a small amount that sometimes doesn’t even show up on a CT scan.” 

In addition to being able to identify patients who may have a brain bleed, the BrainScope One uses the same EEG signal to determine the presence and severity of a concussion.  The device automatically and quickly compares the patient’s EEG to a large database of EEGs from healthy patients of the same age to determine their level of brain function impairment. This assessment function is appropriately named the Brain Function Index.

“Along with determining if there’s a structural injury, the BrainScope also uses EEG to determine if there is functional brain impairment,” Vinocur continues. “It uses big data from years and years of EEGs of normal brain function, so when you use it with an athlete it compares their EEG waves with those of thousands of people who never had a head injury. Then it can show you if the athlete’s Brain Function Index is lower than what it should be.”

In the words of Dr. Mehdiratta, “The Brain Function Index determines the degree of brain injury that’s occurred and guides clinical management and return to play decisions.” 

To further assess a patient’s level of brain impairment, BrainScope’s device also has two rapid neurocognitive (brain processing capability) tests. On the device, the patient takes these tests which measure  reaction time, decision making, attention span, and short-term memory, and once again their results are compared to healthy patients of the same age to assess their brain’s function.  In addition, an extensive digital library of standard concussion assessment tools is available on the device.

The BrainScope One’s ability to quickly provide this level of objective assessment in a sideline setting has quickly drawn the attention of Professional and University sports teams. For Stacey Czaplewski, MAEd, LAT, ATC, Head Athletic Trainer at Winona State University, the BrainScope One also helps athletes feel confident that they are receiving the best care possible. “We’ve been using the BrainScope for close to a year and what has been really positive about it is our student-athletes realize that it’s another layer of protection for them, and that it helps us treat their concussion and see when a referral is absolutely necessary,” she says. “When we pull it out it reassures them that we’re trying to test everything possible.”

Czaplewski also enjoys how quick and easy it is to use. “You get instantaneous feedback as soon as you download the data from the electrodes in the brainwaves, and the whole process only takes a few minutes,” she explains. “It’s also very simple to determine whether a referral is needed or not. The results are very easy to read and can help you decide what the next step should be.”

Dr. Mehdiratta shared, “For example, I recently treated a quarterback who had two concussions in a short period of time and his Brain Function Index was very low. As a result, we asked him not to play until we’re able see how he does with rehabilitation.”

Having this objective data to show athletes can be crucial to making sure they understand the significance of the injury. “It’s sometimes hard to get athletes to take their injury seriously,” says Vinocur. “They don’t want to miss out, they want to play in the big games, so they try to shake it off and minimize things. But now we have some objective data and we can show them how their Brain Function Index compares to thousands of people who have never had a concussion. It certainly makes it easier for the physician, athletic trainer, parent, and coach to get the athlete to understand it’s a significant injury and they need to rest and take time away from their sport.” 

Not only is the BrainScope One making concussion assessment easier and more objective, it is also making it more efficient. CT scans and trips to the emergency room can be costly and unnecessary, yet injured athletes often end up there anyway. That no longer has to be the case. 

“Though it doesn’t replace CT scans, I think the BrainScope is going to help reduce unnecessary CT scans,” says Mehdiratta. “In my practice, I’ve also seen that the BrainScope can reduce the cost of care and improve patient satisfaction overall.”

BrainScope One is currently FDA cleared for assessing people 18-85 years old, within three days of injury. 


BrainScope Honors Veterans Day and Supports U.S. Army Deployment of Traumatic Brain Injury (TBI) and Concussion Assessment Devices

BETHESDA, MD. November 13, 2018– BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today that it has fulfilled orders for over 170 BrainScope One handheld devices and over 7,500 individual patient headsets to U.S. Army bases across the world. U.S. Army medics and clinicians continue to receive the training necessary to support the assessment of military personnel that may have experienced an mTBI, providing access for service members at home and abroad.

BrainScope Grand Rounds Series- Publication Navigator

The BrainScope One system provides objective data that helps clinicians answer two key questions in mildly presenting head-injured patients:

1. Is it likely that there is a structural brain injury that would be visible on a CT scan?

2. Is there evidence of functional brain impairment that could indicate a concussion?

The video below highlights a decade worth of research and development of the BrainScope One device. This includes 24 investigator-initiated publications describing clinical usability, the standard of care comparisons, and the validation of the BrainScope One algorithms.

Grand Round Videos Presented By Leslie Prichep, Ph.D Chief Scientific Officer, BrainScope Company Inc. Adjunct Professor, Department of Psychiatry New York University School of Medicine

The following four videos are intended to educate healthcare professionals on the fundamental scientific and clinical basis of the BrainScope One device. They are not intended to be a substitute for device labeling. Please consult with BrainScope for detailed device labeling such as Indications for Use and Instruction / Directions for Use.

BrainScope Grand Rounds Series- Validation Trial

The video below focuses on BrainScope One’s successful FDA validation trial providing an overview of algorithm development, trial design and a summary of the validation trial results.

Grand Round Videos Presented By Leslie Prichep, Ph.D Chief Scientific Officer, BrainScope Company Inc. Adjunct Professor, Department of Psychiatry New York University School of Medicine

BrainScope Grand Rounds Series- Brain Function Index

The video below explains one of two of BrainScope One’s EEG-based brain injury assessment capabilities, the Brain Function Index. The BFI compares the patient’s brain electrical activity to that of a comparable non-injured population to objectively determine the likelihood, and severity, of brain function impairment.

Grand Round Videos Presented By Leslie Prichep, Ph.D Chief Scientific Officer, BrainScope Company Inc. Adjunct Professor, Department of Psychiatry New York University School of Medicine

BrainScope Grand Rounds Series- Structural Injury Classifier

The video below explains one of two of BrainScope One’s EEG-based brain injury assessment capabilities, the Structural Injury Classifier. The SIC provides clinicians with objective results that indicate the likelihood of a structural brain injury being present or visible on a CT Scan.

Grand Round Videos Presented By Leslie Prichep, Ph.D Chief Scientific Officer, BrainScope Company Inc. Adjunct Professor, Department of Psychiatry New York University School of Medicine

Hurt Your Head? How Do You Rule Out A Brain Bleed? Do You Have A Concussion?

BrainScope One is a new, accurate, cost-effective, radiation-free medical device, cleared by the FDA, that offers a full assessment of your head injury. This assessment tool collects objective information right from your brain! BrainScope One answers two important questions for your doctor: Is there a structural injury? Is there a functional abnormality? BrainScope One can assist your physician in making an objective decision on whether to send you to the ER, start treatment for a concussion, or send you home with a clean bill of health. While not a replacement to CT, BrainScope One assessment can be done at a fraction of the cost of a CT, it can be done at your neighborhood doctor’s office, urgent care setting or yes, even in the ER!

Health Beat: BrainScope test for concussion

University linebacker Zane Ventimiglia suffered not one, but two concussions last season. He didn't see either hit coming, but felt them after.

"I remember being pretty off-kilter, not able to balance well," recalled Ventimiglia, 21.

Athletic director Nathan Wilder said right after injury, trainers have to rely partly on subjective tests, like how an athlete looks or says he feels.

"These kids are pretty resilient. They'll take a hit, come off and say they're OK. Then, a couple of minutes later, they're not," Wilder said.

Now, there's a new, portable device designed to give an objective assessment. The BrainScope measures brain waves.

BrainScope Receives $4.5 Million Department of Defense Contract to Add Ocular Assessment to Future Concussion Products

Artificial Intelligence and Multi-Modal Capabilities to Optimize Personalized Concussion Assessment

BETHESDA, MD. September 4, 2018– BrainScope today announced that it has been awarded a research contract by the United States Department of Defense (DOD) valued at $4.5 million to create and integrate ocular capabilities into its handheld, multi-parameter mild Traumatic Brain Injury (mTBI) and concussion products. 

BrainScope’s initial product in the market, BrainScope One, is the first FDA-cleared medical device to offer capabilities to assess the full spectrum of brain injury – from concussions (functional abnormality) to brain bleeds (structural injury) using EEG and other parameters which together provide the clinician a panel of capabilities to help with their clinical diagnosis.  With this research contract, BrainScope will add specific capabilities related to assessment of the patient’s eyes which will be incorporated in future versions of BrainScope’s products.     

BrainScope Receives Prix Galien Award Nomination for Its Concussion and Traumatic Brain Injury Assessment Product

BETHESDA, MD.--(BUSINESS WIRE)--BrainScope today announced its second consecutive nomination for the 2018 Annual Prix Galien USA Awards for “Best Medical Technology” product. Its flagship BrainScope One product is a multi-modal, comprehensive, handheld capability to help clinicians objectively and rapidly assess and triage head injured patients directly at the point of care.

Over 30% Potential Cost Reduction to Payers and Patients through Integration of BrainScope One for Mild Traumatic Brain Injury / Concussion Assessment

An Economic and Actuarial Model Demonstrates Substantial Cost Benefit to Health Insurers and Patients

BETHESDA, MD. June 28, 2018 – BrainScope announced today the release of a white paper which demonstrates a significant positive impact on the costs to the healthcare system from integrating BrainScope One into the assessment of mild traumatic brain injury / concussion. Escalating awareness of the consequences of traumatic brain injury, even when mild, has resulted in an increasing burden to the healthcare system of $76.5 billion annually. Overall findings of the white paper, authored by a well-respected team comprised of an economist and actuaries, demonstrated that the use of BrainScope One in the Emergency Department and Community settings (including Urgent Care Centers) could result in a significant reduction of costs of up to 32.2%. This is accomplished by a combination of diversion from hospital emergency departments to less expensive care settings, as well as a significant reduction in the number of unnecessary CT scans…

Economic Impact on the Healthcare System using an FDA-Cleared Mild Brain Injury/Concussion Assessment Device

Read full white paper here: BrainScope One Economic Analyzer Model White Paper

Abstract

Over 30% Cost Savings to Payers and Patients Calculated from the BrainScope One Economic Analyzer Model (BEAM)

Escalating awareness of the short and long-term consequences of traumatic head injury, even when mild, has resulted in an increasing burden to the health care system to the extent of $76.5 billion annually. This white paper demonstrates potential cost reductions as high as 32.2%, shared between payers and patients when the BrainScope® One medical device is integrated into the patient care pathway.

Adoption of BrainScope One expands care access points for head injury to Urgent Care Centers (UCC) and Physician offices, more cost efficient and accessible environments. It can also improve patient triage in the Emergency Department (ED) by diverting patients from unnecessary CT scans. BrainScope One has been demonstrated to aid in more objective, accurate, rapid, and safer diagnosis of mild Traumatic Brain injury (mTBI/concussion), resulting in significant benefits across the healthcare system. This paper assesses BrainScope One’s impact on the health care system and specifically examines the potential cost savings to patients and payers using the BrainScope Economic Analyzer Model (BEAM). Utilizing realistic inputs, this model illustrates the significant opportunity for cost savings (as high as 32%) through adoption of BrainScope One.

Rockville, Maryland Urgent Care Uses Revolutionary Brain Injury Assessment Device Backed By The NFL To Reduce CT Scan Recommendations

View Original Article on Digital Journal

ROCKVILLE, MARYLAND - Identifying and detecting brain injuries early is paramount for patients as brain damage associated with concussion, stroke, tumors and other illnesses can dramatically compromise a patient's quality of life.

To effectively treat adult patients with a suspected brain injury one urgent care in Rockville, Maryland, Physicians Now, added a groundbreaking medical technology called BrainScope One to their arsenal of diagnostic tools. BrainScope One provides their providers and staff with greater assurance to objectively diagnosis the full spectrum of brain injuries, including concussions.

BrainScope Initiates Teenage and Young Adult Multi-Site Clinical Study for Concussion Assessment Product

BETHESDA, MD May 31, 2018 – BrainScope, a medical neurotechnology company focused on concussion and mild traumatic brain injury (mTBI) assessment, announced today the initiation of a large, multi-site clinical research study enrolling subjects ages 13-25 years who sustained a head injury from a variety of causes, including sports-related head injuries. Designed as a prospective, observational investigation, eligible patients who sustained a head injury will be recruited from concussion clinics and high schools surrounding the participating universities conducting the study. 

“The initiation of this large clinical study is a significant milestone in the development of BrainScope’s next-generation brain injury assessment products to include teenage patients suspected of a concussion,” said Michael Singer, CEO of BrainScope.“We are aggressively pursuing this very large demographic with plans to introduce a teenage-focused product in the near-term,” stated Singer.

Medics start using scanner that could detect TBI earlier

By J.P. LAWRENCE | STARS AND STRIPES
Published: May 27, 2018
Full Source

AP LIGHTNING, Afghanistan -- Soldiers are trying out a high-tech brain scanner that tests for mild traumatic brain injuries.

The 1st Security Force Assistance Brigade is the first unit to use the smartphone-sized BrainScope device in the field.

Capt. Nicholas Koreerat, a physical therapist in the 1st SFAB, trained newly-arrived medics from the 2nd Squadron (Armored), 1st Cavalry, 4th Infantry Division on the device Saturday at Advising Post Lightning near Gardez.

Prevacus Partners with BrainScope for Upcoming Drug Study on Concussion

TALLAHASSEE, Fla., May 18, 2018 /PRNewswire/ -- Prevacus, Inc., a leading biopharmaceutical company focused on developing treatments for concussion (mild traumatic brain injury (mTBI)) and other neurological disorders today announced a partnership with BrainScope for use of their FDA-cleared BrainScope One device in Prevacus' upcoming Phase 1b clinical research study as an objective biomarker of brain function. Prevacus and BrainScope are supported in their efforts to find a solution to concussions for youth and professional athletes by 3 Super Bowl MVP quarterbacks including Brett Favre, Kurt Warner and Mark Rypien.

Potential to Reduce Emergency Department Referrals From Urgent Care Centers By Up To 75% for Mildly Presenting Head Injured Patients

Read full white paper here: BrainScope One Urgent Care ED Diversion White Paper – May 2018

Abstract
The standard of care today for assessment of traumatic brain injury (TBI) in the Emergency Department (ED) remains the head CT scan, despite the fact that 91% of those scanned are reported to be negative for structural brain injury. Since approximately 95% of head injured patients present as mild, there are a very large number of unnecessary CT scans performed for the mTBI/concussion population. Urgent Care Centers (UCC) have the potential to significantly impact on initial triage and assessment of mild head injured patients, yet today standard clinical assessment capabilities in UCC result in a large percentage of such patients being referred to the ED for CT imaging, most often found to be negative. The ability to objectively assess these patients at the UCC could greatly improve evaluation and care of the mTBI/concussion population. BrainScope One is a novel handheld, rapid, easy to use, FDA cleared medical device to aid in the objective assessment of full spectrum of brain injury, including the likelihood of a structural brain injury visible on CT, with high accuracy shown in a prospective independent FDA validation trial. This White Paper evaluates the reduction of unnecessary UCC referrals to the ED for CTs when BrainScope One was integrated into the clinical decision pathway, based on 196 patients whose data was entered data into the BrainScope One Registry by 12 UCC. Significant reductions in ED referrals were realized (as high as 75%) when BrainScope One was used to aid in referral decisions across a wide range (100% to 50%) of prior clinical practice referral rates, supporting the potential to significantly impact on ED diversion and reduction of unnecessary CT scans in the mild brain injury population, benefiting the patient and reducing costs to the healthcare system.

Using BrainScope One in Urgent Care Centers Shows Potential 75% Reduction in Head Injury Referrals to Emergency Departments

BrainScope One Provides Objective, Actionable Information for Assessment of Mildly Presenting Head Injured Patients in Urgent Care Centers, Emergency Departments, and Other Settings

BETHESDA, MD. MAY 7, 2018 – BrainScope announced today the release of a white paper authored by Urgent Care physicians which demonstrated that the FDA-cleared BrainScope One had the potential to reduce unnecessary Emergency Department referrals by up to seventy-five percent.  BrainScope One offers a rapid (within minutes) assessment of the full spectrum of traumatic brain injury (TBI), including concussion, using digital electroencephalography (EEG) and other modalities, facilitating accurate and timely decision-making for first responders, clinicians, and other health practitioners at the point of care wherever an injury occurs. 

Close to 5 million people who experience a TBI seek care and treatment at hospital Emergency Departments (EDs) in the U.S. each year, where over 80% of these patients are evaluated using a computed tomography (CT) scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment.  Over 90% of these CT scans are found to be negative, unnecessarily exposing patients to radiation, long wait times, and high costs.   

BrainScope One Demonstrated the Potential to Reduce Head CT Scans By One-Third in Emergency Department Use

BETHESDA, MD. APRIL 30, 2018 – BrainScope announced today the release of a white paper authored by physicians at Washington University Barnes Jewish Medical Center in St. Louis, which demonstrated that the FDA-cleared BrainScope One had the potential to reduce the use of unnecessary head CT scans by one-third in a hospital Emergency Department setting.

Today most patients seen in the emergency room with a suspected head injury receive a computed tomography (CT) scan of the head to detect brain tissue damage, or intracranial lesions, that may require treatment; however, the vast majority of these patients do not have detectable intracranial lesions visible on the CT scan. The availability of BrainScope One can help health care professionals determine the need for a CT scan and help prevent unnecessary neuroimaging and associated radiation exposure to patients.

Using data entered in BrainScope’s national Registry, the white paper authors compared 64 patients who were referred for CT scan…